An artificial heart is a device that replaces the
heart
The heart is a muscular organ in most animals. This organ pumps blood through the blood vessels of the circulatory system. The pumped blood carries oxygen and nutrients to the body, while carrying metabolic waste such as carbon dioxide t ...
. Artificial hearts are typically used to bridge the time to
heart transplantation
A heart transplant, or a cardiac transplant, is a surgical transplant procedure performed on patients with end-stage heart failure or severe coronary artery disease when other medical or surgical treatments have failed. , the most common procedu ...
, or to permanently replace the heart in the case that a heart transplant (from a deceased human or, experimentally, from a deceased genetically engineered pig) is impossible. Although other similar inventions preceded it from the late 1940s, the first artificial heart to be successfully implanted in a human was the Jarvik-7 in 1982, designed by a team including
Willem Johan Kolff
Willem Johan "Pim" Kolff (February 14, 1911 – February 11, 2009) was a pioneer of hemodialysis, artificial heart, as well as in the entire field of artificial organs. Willem was a member of the Kolff family, an old Dutch patrician fami ...
,
William DeVries
William Castle DeVries (born December 19, 1943) is an American cardiothoracic surgeon, mainly known for the first transplant of a TAH (total artificial heart) using the Jarvik-7 model.
Early years and Medical School
William DeVries was born ...
and
Robert Jarvik.
An artificial heart is distinct from a
ventricular assist device
A ventricular assist device (VAD) is an electromechanical device for assisting cardiac circulation, which is used either to partially or to completely replace the function of a failing heart. The function of a VAD differs from that of an artific ...
(VAD; for either one or both of the ventricles, the heart's lower chambers), which can be a permanent solution also, or the
intra-aortic balloon pump
The intra-aortic balloon pump (IABP) is a mechanical device that increases myocardial oxygen perfusion and indirectly increases cardiac output through afterload reduction. It consists of a cylindrical polyurethane balloon that sits in the aorta, ...
– both devices are designed to support a failing heart. It is also distinct from a
cardiopulmonary bypass
Cardiopulmonary bypass (CPB) is a technique in which a machine temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and oxygen to the body. The CPB pump itself is often referred to as a he ...
machine, which is an external device used to provide the functions of both the heart and
lung
The lungs are the primary organs of the respiratory system in humans and most other animals, including some snails and a small number of fish. In mammals and most other vertebrates, two lungs are located near the backbone on either side of t ...
s, used only for a few hours at a time, most commonly during
cardiac surgery
Cardiac surgery, or cardiovascular surgery, is surgery on the heart or great vessels performed by cardiac surgeons. It is often used to treat complications of ischemic heart disease (for example, with coronary artery bypass grafting); to corr ...
. It is also distinct from a ventilator, used to support failing lungs, or the
extracorporeal membrane oxygenation
Extracorporeal membrane oxygenation (ECMO), also known as extracorporeal life support (ECLS), is an extracorporeal technique of providing prolonged cardiac and respiratory support to persons whose heart and lungs are unable to provide an adequat ...
(ECMO), which is used to support those with both inadequate heart and lung function for up to days or weeks, unlike the bypass machine.
History
Origins
A synthetic replacement for a heart remains a long-sought "holy grail" of modern medicine. The obvious benefit of a functional artificial heart would be to lower the need for
heart transplant
A heart transplant, or a cardiac transplant, is a surgical transplant procedure performed on patients with end-stage heart failure or severe coronary artery disease when other medical or surgical treatments have failed. , the most common proce ...
s because the demand for organs always greatly exceeds supply.
Although the heart is conceptually a pump, it embodies subtleties that defy straightforward emulation with synthetic materials and power supplies. Consequences of these issues include severe
foreign-body rejection and external batteries that limit mobility. These complications limited the lifespan of early human recipients from hours to days.
Early development
The first artificial heart was made by the Soviet scientist
Vladimir Demikhov
Vladimir Petrovich Demikhov (russian: Владимир Петрович Демихов; July 31, 1916 – November 22, 1998) was a Soviet scientist and organ transplantation pioneer, who performed several transplants in the 1940s and 1 ...
in 1938. It was implanted in a dog.
On 2 July 1952, 41-year-old
Henry Opitek
Henry Opitek (January 6, 1911 – March 13, 1981) became the first patient to survive open heart surgery in 1952.
On July 3, 1952, Opitek, a 41-year-old male suffering from shortness of breath, made medical history at Harper University Hospital ...
, suffering from shortness of breath, made medical history at Harper University Hospital at
Wayne State University
Wayne State University (WSU) is a public research university in Detroit, Michigan. It is Michigan's third-largest university. Founded in 1868, Wayne State consists of 13 schools and colleges offering approximately 350 programs to nearly 25,000 ...
in Michigan. The
Dodrill-GMR heart machine, considered to be the first operational mechanical heart, was successfully used while performing heart surgery.
Ongoing research was done on calves at
Hershey Medical Center
Penn State Health Milton S. Hershey Medical Center (MSHMC) is a 628-bed non-profit, tertiary, research and academic medical center located in Hershey, Pennsylvania, servicing the Central Pennsylvania area. MSHMC is the region's only university-le ...
, Animal Research Facility, in Hershey, Pennsylvania, during the 1970s.
Forest Dewey Dodrill
Forest Dewey Dodrill (January 26, 1902 – June 28, 1997) was a medical doctor at Harper University Hospital at Wayne State University in Michigan who performed the first successful open heart surgery using a mechanical pump.
Biography
Dodrill wa ...
, working closely with Matthew Dudley, used the machine in 1952 to bypass Henry Opitek's left ventricle for 50 minutes while he opened the patient's left atrium and worked to repair the mitral valve. In Dodrill's post-operative report, he notes, "To our knowledge, this is the first instance of survival of a patient when a mechanical heart mechanism was used to take over the complete body function of maintaining the blood supply of the body while the heart was open and operated on."
A
heart–lung machine
Cardiopulmonary bypass (CPB) is a technique in which a machine temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and oxygen to the body. The CPB pump itself is often referred to as a ...
was first used in 1953 during a successful open heart surgery.
John Heysham Gibbon
John Heysham Gibbon (September 29, 1903 – February 5, 1973) was an American surgeon best known for inventing the heart–lung machine and performing subsequent open-heart surgery, open-heart surgeries which revolutionized heart surger ...
, the inventor of the machine, performed the operation and developed the heart–lung substitute himself.
Following these advances, scientific interest for the development of a solution for heart disease developed in numerous research groups worldwide.
Early designs of total artificial hearts
In 1949, a precursor to the modern artificial heart pump was built by doctors William Sewell and
William Glenn
William Wallace Lumpkin Glenn (August 12, 1914 – March 10, 2003) was an American cardiac surgeon who co-created an early version of an artificial heart and was the developer of a technique for the treatment of congenital heart defects.
Glen ...
of the
Yale School of Medicine
The Yale School of Medicine is the graduate medical school at Yale University, a private research university in New Haven, Connecticut. It was founded in 1810 as the Medical Institution of Yale College and formally opened in 1813.
The primary te ...
using an
Erector Set
Erector Set (trademark styled as "ERECTOR") was a brand of metal toy construction sets which were originally patented by Alfred Carlton Gilbert and first sold by his company, the Mysto Manufacturing Company of New Haven, Connecticut in 1913. In ...
, assorted odds and ends, and dime-store toys. The external pump successfully bypassed the heart of a dog for more than an hour.
Paul Winchell
Paul Winchell (''né'' Wilchinsky; December 21, 1922 – June 24, 2005) was an American actor, comedian, humanitarian, inventor and ventriloquist whose career flourished in the 1950s and 1960s. From 1950 to 1954, he hosted ''The Paul Winchell S ...
invented an artificial heart with the assistance of
Henry Heimlich
Henry Judah Heimlich (February 3, 1920 – December 17, 2016) was an American thoracic surgeon and medical researcher. He is widely credited as the inventor of the Heimlich maneuver, a technique of abdominal thrusts for stopping choking, first ...
(the inventor of the
Heimlich maneuver
Abdominal thrusts, also known as the Heimlich maneuver or Heimlich manoeuvre, is a first aid procedure used to treat upper airway obstructions (or choking) by foreign objects. American doctor Henry Heimlich is often credited for its creation. ...
) and held the first patent for such a device. The University of Utah developed a similar apparatus around the same time, but when they tried to patent it, Winchell's heart was cited as prior art. The university requested that Winchell donate the heart to the University of Utah, which he did.
There is some debate as to how much of Winchell's design Robert Jarvik used in creating Jarvik's artificial heart. Heimlich states, "I saw the heart, I saw the patent and I saw the letters. The basic principle used in Winchell's heart and Jarvik's heart is exactly the same. " Jarvik denies that any of Winchell's design elements were incorporated into the device he fabricated for humans which was successfully implanted into Barney Clark in 1982.
On 12 December 1957,
Willem Johan Kolff
Willem Johan "Pim" Kolff (February 14, 1911 – February 11, 2009) was a pioneer of hemodialysis, artificial heart, as well as in the entire field of artificial organs. Willem was a member of the Kolff family, an old Dutch patrician fami ...
, the world's most prolific inventor of artificial organs, implanted an artificial heart into a dog at Cleveland Clinic. The dog lived for 90 minutes.
In 1958,
Domingo Liotta
Domingo Santo Liotta (29 November 1924 – 31 August 2022) was an Argentine surgeon and pioneer of heart surgery who created multiple cardiac prostheses, including the first total artificial heart used in a human being.
Early life
Domingo Sant ...
initiated the studies of TAH replacement at Lyon, France, and in 1959–60 at the
National University of Córdoba
The National University of Córdoba ( es, Universidad Nacional de Córdoba,) is an institution of higher education in the city of Córdoba, Argentina.
Founded in 1613, the university is the oldest in Argentina, the third oldest university of t ...
, Argentina. He presented his work at the meeting of the American Society for Artificial Internal Organs held in Atlantic City in March 1961. At that meeting, Liotta described the implantation of three types of orthotopic (inside the pericardial sac) TAHs in dogs, each of which used a different source of external energy: an implantable electric motor, an implantable rotating pump with an external electric motor, and a pneumatic pump.
In 1964, the
National Institutes of Health
The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
started the Artificial Heart Program, with the goal of putting an artificial heart into a human by the end of the decade.
[Sandeep Jauhar: ''The Artificial Heart.'' New England Journal of Medicine (2004): 542–544.] The purpose of the program was to develop an implantable artificial heart, including the power source, to replace a failing heart.
In February 1966,
Adrian Kantrowitz
Adrian Kantrowitz (October 4, 1918 – November 14, 2008) was an American cardiac surgeon whose team performed the world's second heart transplant attempt (after Christiaan Barnard) at Maimonides Medical Center in Brooklyn, New York on December 6, ...
rose to international prominence when he performed the world's first permanent implantation of a partial mechanical heart (left ventricular assist device) at
Maimonides Medical Center
Maimonides Medical Center is a non-profit, non-sectarian hospital located in Borough Park, Brooklyn, Borough Park, in the New York City Borough (New York City), borough of Brooklyn, in the U.S. state of New York (state), New York. Maimonides is b ...
.
In 1967, Kolff left Cleveland Clinic to start the Division of Artificial Organs at the
University of Utah
The University of Utah (U of U, UofU, or simply The U) is a public research university in Salt Lake City, Utah. It is the flagship institution of the Utah System of Higher Education. The university was established in 1850 as the University of De ...
and pursue his work on the artificial heart.
# In 1973, a calf named Tony survived for 30 days on an early Kolff heart.
# In 1975, a bull named Burk survived 90 days on the artificial heart.
# In 1976, a calf named Abebe lived for 184 days on the Jarvik 5 artificial heart.
# In 1981, a calf named Alfred Lord Tennyson lived for 268 days on the Jarvik 5.
Over the years, more than 200 physicians, engineers, students and faculty developed, tested and improved Kolff's artificial heart. To help manage his many endeavors, Kolff assigned project managers. Each project was named after its manager. Graduate student Robert Jarvik was the project manager for the artificial heart, which was subsequently renamed the Jarvik 7.
In 1981,
William DeVries
William Castle DeVries (born December 19, 1943) is an American cardiothoracic surgeon, mainly known for the first transplant of a TAH (total artificial heart) using the Jarvik-7 model.
Early years and Medical School
William DeVries was born ...
submitted a request to the FDA for permission to implant the Jarvik 7 into a human being. On 1 December 1982, William DeVries implanted the Jarvik 7 artificial heart into Barney Clark, a dentist from Seattle who had severe
congestive heart failure
Heart failure (HF), also known as congestive heart failure (CHF), is a syndrome, a group of signs and symptoms caused by an impairment of the heart's blood pumping function. Symptoms typically include shortness of breath, excessive fatigue, a ...
. Clark lived for 112 days tethered to an external pneumatic compressor, a device weighing some , but during that time he experienced prolonged periods of confusion and a number of instances of bleeding, and asked several times to be allowed to die.
First clinical implantation of a total artificial heart
On 4 April 1969,
Domingo Liotta
Domingo Santo Liotta (29 November 1924 – 31 August 2022) was an Argentine surgeon and pioneer of heart surgery who created multiple cardiac prostheses, including the first total artificial heart used in a human being.
Early life
Domingo Sant ...
and
Denton A. Cooley replaced a dying man's heart with a mechanical heart inside the chest at
The Texas Heart Institute
The Texas Heart Institute is an independent, nonprofit organization that is improving cardiovascular health through trailblazing research, thought leadership, education, and patient care to forge a better future for those with cardiovascular diseas ...
in
Houston
Houston (; ) is the most populous city in Texas, the most populous city in the Southern United States, the fourth-most populous city in the United States, and the sixth-most populous city in North America, with a population of 2,304,580 in ...
as a bridge for a transplant. The man woke up and began to recover. After 64 hours, the pneumatic-powered artificial heart was removed and replaced by a donor heart. However thirty-two hours after transplantation, the man died of what was later proved to be an acute pulmonary infection, extended to both lungs, caused by fungi, most likely caused by an
immunosuppressive drug
Immunosuppressive drugs, also known as immunosuppressive agents, immunosuppressants and antirejection medications, are drugs that inhibit or prevent activity of the immune system.
Classification
Immunosuppressive drugs can be classified into ...
complication.
The original prototype of Liotta-Cooley artificial heart used in this historic operation is prominently displayed in the
Smithsonian Institution
The Smithsonian Institution ( ), or simply the Smithsonian, is a group of museums and education and research centers, the largest such complex in the world, created by the U.S. government "for the increase and diffusion of knowledge". Founded ...
's
National Museum of American History
The National Museum of American History: Kenneth E. Behring Center collects, preserves, and displays the heritage of the United States in the areas of social, political, cultural, scientific, and military history. Among the items on display is t ...
"Treasures of American History" exhibit in Washington, D.C.
First clinical applications of a permanent pneumatic total artificial heart
The first clinical use of an artificial heart designed for permanent implantation rather than a bridge to transplant occurred in 1982 at the
University of Utah
The University of Utah (U of U, UofU, or simply The U) is a public research university in Salt Lake City, Utah. It is the flagship institution of the Utah System of Higher Education. The university was established in 1850 as the University of De ...
. Artificial kidney pioneer
Willem Johan Kolff
Willem Johan "Pim" Kolff (February 14, 1911 – February 11, 2009) was a pioneer of hemodialysis, artificial heart, as well as in the entire field of artificial organs. Willem was a member of the Kolff family, an old Dutch patrician fami ...
started the Utah artificial organs program in 1967. There, physician-engineer
Clifford Kwan-Gett invented two components of an integrated pneumatic artificial heart system: a ventricle with hemispherical diaphragms that did not crush red blood cells (a problem with previous artificial hearts) and an external heart driver that inherently regulated blood flow without needing complex control systems. Independently,
Paul Winchell
Paul Winchell (''né'' Wilchinsky; December 21, 1922 – June 24, 2005) was an American actor, comedian, humanitarian, inventor and ventriloquist whose career flourished in the 1950s and 1960s. From 1950 to 1954, he hosted ''The Paul Winchell S ...
designed and patented a similarly shaped ventricle and donated the patent to the Utah program. Throughout the 1970s and early 1980s, veterinarian Donald Olsen led a series of calf experiments that refined the artificial heart and its surgical care. During that time, as a student at the University of Utah,
Robert Jarvik combined several modifications: an ovoid shape to fit inside the human chest, a more blood-compatible polyurethane developed by biomedical engineer Donald Lyman, and a fabrication method by Kwan-Gett that made the inside of the ventricles smooth and seamless to reduce dangerous stroke-causing blood clots. On 1 December 1982,
William DeVries
William Castle DeVries (born December 19, 1943) is an American cardiothoracic surgeon, mainly known for the first transplant of a TAH (total artificial heart) using the Jarvik-7 model.
Early years and Medical School
William DeVries was born ...
implanted the artificial heart into retired dentist Barney Bailey Clark (born 21 January 1921), who survived 112 days with the device, dying on 23 March 1983.
Bill Schroeder became the second recipient and lived for a record 620 days.
Contrary to popular belief and erroneous articles in several periodicals, the Jarvik heart was not banned for permanent use. Today, the modern version of the Jarvik 7 is known as the
SynCardia temporary Total Artificial Heart. It has been implanted in more than 1,350 people as a bridge to transplantation.
In the mid-1980s, artificial hearts were powered by dishwasher-sized pneumatic power sources whose lineage went back to
Alfa Laval
Alfa Laval AB is a Sweden, Swedish corporation, company, founded in 1883 by Gustaf de Laval and :sv:Oscar Lamm, Oscar Lamm. The company, which started in providing centrifugal separation solutions for dairy (see Separator (milk)), now deals in th ...
milking machines
A dairy is a business enterprise established for the harvesting or processing (or both) of animal milk – mostly from cows or buffaloes, but also from goats, sheep, horses, or camels – for human consumption. A dairy is typically located on ...
. Moreover, two sizable catheters had to cross the body wall to carry the pneumatic pulses to the implanted heart, greatly increasing the risk of infection. To speed development of a new generation of technologies, the
National Heart, Lung, and Blood Institute
The National Heart, Lung, and Blood Institute (NHLBI) is the third largest Institute of the National Institutes of Health, located in Bethesda, Maryland, United States. It is tasked with allocating about $3.6 billion in FY 2020 in tax revenue to ...
opened a competition for implantable electrically powered artificial hearts. Three groups received funding:
Cleveland Clinic
Cleveland Clinic is a nonprofit American academic medical center based in Cleveland, Ohio. Owned and operated by the Cleveland Clinic Foundation, an Ohio nonprofit corporation established in 1921, it runs a 170-acre (69 ha) campus in Cleveland, ...
in Cleveland, Ohio; the College of Medicine of
Pennsylvania State University
The Pennsylvania State University (Penn State or PSU) is a Public university, public Commonwealth System of Higher Education, state-related Land-grant university, land-grant research university with campuses and facilities throughout Pennsylvan ...
(
Penn State Hershey Medical Center
Penn State Health Milton S. Hershey Medical Center (MSHMC) is a 628-bed non-profit, tertiary, research and academic medical center located in Hershey, Pennsylvania, servicing the Central Pennsylvania area. MSHMC is the region's only university-le ...
) in Hershey, Pennsylvania; and AbioMed, Inc. of Danvers, Massachusetts. Despite considerable progress, the Cleveland program was discontinued after the first five years.
First clinical application of an intrathoracic pump
On 19 July 1963, E. Stanley Crawford and
Domingo Liotta
Domingo Santo Liotta (29 November 1924 – 31 August 2022) was an Argentine surgeon and pioneer of heart surgery who created multiple cardiac prostheses, including the first total artificial heart used in a human being.
Early life
Domingo Sant ...
implanted the first clinical Left Ventricular Assist Device (LVAD) at
The Methodist Hospital
Houston Methodist Hospital is the flagship quaternary care hospital of Houston Methodist academic medical center. Located in the Texas Medical Center in Houston, Texas, Houston Methodist Hospital was established in 1919 during the height of the ...
in Houston, Texas, in a patient who had a cardiac arrest after surgery. The patient survived for four days under mechanical support but did not recover from the complications of the cardiac arrest; finally, the pump was discontinued, and the patient died.
First clinical application of a paracorporeal pump
![1966 DeBakey ventricular assist device](https://upload.wikimedia.org/wikipedia/commons/d/d4/1966_DeBakey_ventricular_assist_device.jpg)
On 21 April 1966,
Michael DeBakey
Michael Ellis DeBakey (September 7, 1908 – July 11, 2008) was a Lebanese-American general and cardiovascular surgeon, scientist and medical educator who became Chairman of the Department of Surgery, President, and Chancellor of Baylor College ...
and Liotta implanted the first clinical LVAD in a paracorporeal position (where the external pump rests at the side of the patient) at The Methodist Hospital in Houston, in a patient experiencing cardiogenic shock after heart surgery. The patient developed neurological and pulmonary complications and died after few days of LVAD mechanical support. In October 1966, DeBakey and Liotta implanted the paracorporeal Liotta-DeBakey LVAD in a new patient who recovered well and was discharged from the hospital after 10 days of mechanical support, thus constituting the first successful use of an LVAD for postcardiotomy shock.
First VAD patient with FDA approved hospital discharge
In 1990 Brian Williams was discharged from the
University of Pittsburgh Medical Center
The University of Pittsburgh Medical Center (UPMC) is a $23billion integrated global nonprofit health enterprise that has 92,000 employees, 40 hospitals with more than 8,000 licensed beds, 800 clinical locations including outpatient sites and do ...
(UPMC), becoming the first VAD patient to be discharged with Food and Drug Administration (FDA) approval.
The patient was supported in part by bioengineers from the University of Pittsburgh's McGowan Institute.
Total artificial hearts
Approved medical devices
SynCardia
SynCardia is a company based in Tucson, Arizona, which currently has two separate models available. It is available in a 70cc and 50cc size. The 70cc model is used for biventricular heart failure in adult men, while the 50cc is for children and women. As good results with the TAH as a bridge to
heart transplant
A heart transplant, or a cardiac transplant, is a surgical transplant procedure performed on patients with end-stage heart failure or severe coronary artery disease when other medical or surgical treatments have failed. , the most common proce ...
accumulated, a trial of the CardioWest TAH (developed from the Jarvik 7 and now marketed as the Syncardia TAH) was initiated in 1993 and completed in 2002. The SynCardia was first approved for use in 2004 by the
US Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
.
As of 2014, more than 1,250 patients have received SynCardia artificial hearts.
The device requires the use of the Companion 2 in-hospital driver, approved by the FDA in 2012, or the Freedom Driver System, approved in 2014, which allows some patients to return home, to power the heart with pulses of air.
The drivers also monitor blood flow for each ventricle.
In 2016, Syncardia filed for bankruptcy protection and was later acquired by the private equity firm Versa Capital Management.
Carmat bioprosthetic heart
On 27 October 2008, French professor and leading
heart transplant
A heart transplant, or a cardiac transplant, is a surgical transplant procedure performed on patients with end-stage heart failure or severe coronary artery disease when other medical or surgical treatments have failed. , the most common proce ...
specialist
Alain F. Carpentier announced that a fully implantable artificial heart would be ready for clinical trial by 2011 and for alternative transplant in 2013. It was developed and would be manufactured by him, biomedical firm
CARMAT SA, and venture capital firm Truffle Capital. The prototype used embedded electronic sensors and was made from chemically treated animal tissues, called "biomaterials", or a "pseudo-skin" of
biosynthetic
Biosynthesis is a multi-step, enzyme-Catalysis, catalyzed process where substrate (chemistry), substrates are converted into more complex Product (chemistry), products in living organisms. In biosynthesis, simple Chemical compound, compounds are mo ...
,
microporous material
A microporous material is a material containing pores with diameters less than 2 nm. Examples of microporous materials include zeolites and metal-organic frameworks.
Porous materials are classified into several kinds by their size. The recom ...
s.
According to a press-release by Carmat dated 20 December 2013, the first implantation of its artificial heart in a 75-year-old patient was performed on 18 December 2013 by the Georges Pompidou European Hospital team in Paris (France).
The patient died 75 days after the operation.
In Carmat's design, two chambers are each divided by a membrane that holds hydraulic fluid on one side. A motorized pump moves hydraulic fluid in and out of the chambers, and that fluid causes the membrane to move; blood flows through the other side of each membrane. The blood-facing side of the membrane is made of tissue obtained from a sac that surrounds a cow's heart, to make the device more biocompatible. The Carmat device also uses valves made from cow heart tissue and has sensors to detect increased pressure within the device. That information is sent to an internal control system that can adjust the flow rate in response to increased demand, such as when a patient is exercising. This distinguishes it from previous designs that maintain a constant flow rate.
The Carmat device, unlike previous designs, is meant to be used in cases of terminal heart failure, instead of being used as a bridge device while the patient awaits a transplant. At 900 grams it weighs nearly three times the typical heart and is targeted primarily towards obese men. It also requires the patient to carry around an additional
Li-Ion
A lithium-ion or Li-ion battery is a type of rechargeable battery which uses the reversible Redox, reduction of lithium ions to store energy. It is the predominant battery type used in portable consumer electronics and electric vehicles. It als ...
battery. The projected lifetime of the artificial heart is around 5 years (230 million beats).
In 2016, trials for the Carmat "fully artificial heart" were banned by the National Agency for Security and Medicine in Europe after short survival rates were confirmed. The ban was lifted in May 2017. At that time, a European report stated that Celyad's C-Cure cell therapy for ischemic heart failure
"could only help a subpopulation of Phase III study participants, and Carmat will hope that its artificial heart will be able to treat a higher proportion of heart failure patients".
The Carmat artificial heart was approved for sale in the European Union, receiving a
CE marking
On commercial products, the letters CE (as the logo ) mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certificatio ...
on December 22, 2020. Its stock price increased over a third upon the announcement of the news.
Historical prototypes
Total artificial heart pump
The
U.S. Army
The United States Army (USA) is the land service branch of the United States Armed Forces. It is one of the eight U.S. uniformed services, and is designated as the Army of the United States in the U.S. Constitution.Article II, section 2, cl ...
artificial heart pump was a compact, air-powered unit developed by Kenneth Woodward at
Harry Diamond Laboratories
The Harry Diamond Laboratories (HDL) was a research facility of the Ordnance Development Division of the National Bureau of Standards and later the US Army, most notable for its work on proximity fuzes in World War II. The organization was founded ...
in the early to mid-1960s.
The Army's heart pump was partially made of
plexiglass
Poly(methyl methacrylate) (PMMA) belongs to a group of materials called engineering plastics. It is a transparent thermoplastic. PMMA is also known as acrylic, acrylic glass, as well as by the trade names and brands Crylux, Plexiglas, Acrylite, ...
, and consisted of two valves, a chamber, and a suction flapper.
The pump operated without any moving parts under the principle of fluid amplification – providing a pulsating air pressure source resembling a heartbeat.
POLVAD
Since 1991, the Foundation for Cardiac Surgery Development (FRK) in
Zabrze
Zabrze (; German: 1915–1945: ''Hindenburg O.S.'', full form: ''Hindenburg in Oberschlesien'', Silesian: ''Zŏbrze'', yi, זאַבזשע, Zabzhe) is an industrial city in Silesia in southern Poland, near Katowice. The west district of the Sil ...
, Poland, has been working on developing an artificial heart. Nowadays, the Polish system for heart support POLCAS consists of the artificial ventricle POLVAD-MEV and the three controllers POLPDU-401, POLPDU-402 and POLPDU-501. Presented devices are designed to handle only one patient. The control units of the 401 and 402 series may be used only in hospital due to its big size, method of control and type of power supply. The control unit of 501 series is the latest product of FRK. Due to its much smaller size and weight, it is significantly more mobile solution. For this reason, it can be also used during supervised treatment conducted outside the hospital.
Phoenix-7
In June 1996, a 46-year-old man received a total artificial heart implantation done by
Jeng Wei at Cheng-Hsin General Hospital in
Taiwan
Taiwan, officially the Republic of China (ROC), is a country in East Asia, at the junction of the East and South China Seas in the northwestern Pacific Ocean, with the People's Republic of China (PRC) to the northwest, Japan to the nort ...
. This technologically advanced pneumatic
Phoenix-7 Total Artificial Heart was manufactured by Taiwanese dentist
Kelvin K. Cheng
Kevin K. Cheng (born around 1945), developed the Phoenix total artificial heart, first used in a human in 1985 in an emergency in a person whose donor heart was being acutely rejected. Cheng was a dentist by profession and the Phoenix heart he de ...
, Chinese physician
T. M. Kao, and colleagues at the
Taiwan TAH Research Center
Taiwan, officially the Republic of China (ROC), is a country in East Asia, at the junction of the East and South China Seas in the northwestern Pacific Ocean, with the People's Republic of China (PRC) to the northwest, Japan to the northeas ...
in
Tainan
Tainan (), officially Tainan City, is a Special municipality (Taiwan), special municipality in southern Taiwan facing the Taiwan Strait on its western coast. Tainan is the oldest city on the island and also commonly known as the "Capital City" ...
,
Taiwan
Taiwan, officially the Republic of China (ROC), is a country in East Asia, at the junction of the East and South China Seas in the northwestern Pacific Ocean, with the People's Republic of China (PRC) to the northwest, Japan to the nort ...
. With this experimental artificial heart, the patient's BP was maintained at 90–100/40–55 mmHg and cardiac output at 4.2–5.8 L/min. The patient then received the world's first successful combined heart and kidney transplantation after bridging with a total artificial heart.
Abiomed hearts
The first
AbioCor
AbioCor was a total artificial heart (TAH) developed by the Massachusetts-based company AbioMed. It was fully implantable within a patient, due to a combination of advances in miniaturization, biosensors, plastics and energy transfer. The AbioC ...
to be surgically implanted in a patient was on 3 July 2001.
The AbioCor is made of titanium and plastic with a weight of 0.9 kg (two pounds), and its internal battery can be recharged with a transduction device that sends power through the skin.
The internal battery lasts for half an hour, and a wearable external battery pack lasts for four hours. The FDA announced on 5 September 2006, that the AbioCor could be implanted for humanitarian uses after the device had been tested on 15 patients.
It is intended for critically ill patients who cannot receive a heart transplant.
Some limitations of the current AbioCor are that its size makes it suitable for less than 50% of the female population and only about 50% of the male population, and its useful life is only 1–2 years.
By combining its valved ventricles with the control technology and roller screw developed at Penn State, AbioMed designed a smaller, more stable heart, the AbioCor II. This pump, which should be implantable in most men and 50% of women with a life span of up to five years,
had animal trials in 2005, and the company hoped to get FDA approval for human use in 2008.
After a great deal of experimentation,
Abiomed
Abiomed, Inc. is a medical device technology company that operates as a stand-alone business within Johnson & Johnson's MedTech Segment. Abiomed develops and manufactures temporary external and implantable mechanical circulatory support devices. ...
has abandoned development of total official hearts as of 2015. Abiomed as of 2019 only markets heart pumps, "intended to help pump blood in patients who need short-term support (up to 6 days)", which are not total artificial hearts.
Frazier-Cohn
On 12 March 2011, an experimental artificial heart was implanted in 55-year-old Craig Lewis at The Texas Heart Institute in Houston by
O. H. Frazier and
William Cohn. The device is a combination of two modified
HeartMate II
A ventricular assist device (VAD) is an electromechanical device for assisting cardiac circulation, which is used either to partially or to completely replace the function of a failing heart. The function of a VAD differs from that of an artifici ...
pumps that is currently undergoing bovine trials.
Frazier and Cohn are on the board of the BiVACOR company that develops an artificial heart. BiVACOR has been tested as a replacement for a heart in a sheep.
So far, only one person has benefited from Frazier and Cohn's artificial heart. Craig Lewis had
amyloidosis
Amyloidosis is a group of diseases in which abnormal proteins, known as amyloid fibrils, build up in tissue. There are several non-specific and vague signs and symptoms associated with amyloidosis. These include fatigue, peripheral edema, weight ...
in 2011 when his heart gave out and doctors pronounced that he had only 12 to 24 hours to live. After obtaining permission from his family, Frazier and Cohn replaced his heart with their device. Lewis survived for another 5 weeks after the operation; he eventually died from liver and kidney failure due to his amyloidosis, after which his family asked that his artificial heart be unplugged.
Current prototypes
Soft artificial heart
On 10 July 2017, Nicholas Cohrs and colleagues presented a new concept of a soft total artificial heart in the Journal of Artificial Organs. The heart was developed in the Functionals Materials Laboratory at
ETH Zurich
(colloquially)
, former_name = eidgenössische polytechnische Schule
, image = ETHZ.JPG
, image_size =
, established =
, type = Public
, budget = CHF 1.896 billion (2021)
, rector = Günther Dissertori
, president = Joël Mesot
, ac ...
. (Cohrs was listed as a doctoral student in a group led by Professor Wendelin Stark at ETH Zurich.)
The soft artificial heart (SAH) was created from silicone with the help of 3D printing technology. The SAH is a silicone monoblock. It weighs 390g, has a volume of 679 cm
3 and is operated through pressurized air. "Our goal is to develop an artificial heart that is roughly the same size as the patient's own one and which imitates the human heart as closely as possible in form and function" says Cohrs in an interview. The SAH fundamentally moves and works like a real heart but currently only beats for 3000 beats (which corresponds to a duration of 30 to 50 minutes for an average individual's heart beat)
in a hybrid mock circulation machine.
Following which the silicone membrane (2.3 mm thick) between the Left Ventricle and the Air Expansion Chamber ruptured.
The working life of a more recent Cohrs prototype (using various polymers instead of silicone)
was still limited, according to reports in early 2018, with that model providing a useful life of 1 million heartbeats, roughly ten days in a human body. At the time, Cohrs and his team were experimenting with CAD software and 3D printing, striving to develop a model that would last up to 15 years. "We cannot really predict when we could have a final working heart which fulfills all requirements and is ready for implantation. This usually takes years", said Cohrs.
Others
A
centrifugal pump
Centrifugal pumps are used to transport fluids by the conversion of rotational kinetic energy to the hydrodynamic energy of the fluid flow. The rotational energy typically comes from an engine or electric motor. They are a sub-class of dynamic ...
or an
axial-flow pump
An axial-flow pump, or AFP, is a common type of pump that essentially consists of a propeller (an axial impeller) in a pipe. The propeller can be driven directly by a sealed motor in the pipe or by electric motor or petrol/diesel engines mounted ...
can be used as an artificial heart, resulting in the patient being alive without a
pulse
In medicine, a pulse represents the tactile arterial palpation of the cardiac cycle (heartbeat) by trained fingertips. The pulse may be palpated in any place that allows an artery to be compressed near the surface of the body, such as at the nec ...
. Other pulse-less artificial heart designs include the
HeartMate II
A ventricular assist device (VAD) is an electromechanical device for assisting cardiac circulation, which is used either to partially or to completely replace the function of a failing heart. The function of a VAD differs from that of an artifici ...
from Thoratec, which uses an
Archimedes screw
The Archimedes screw, also known as the Archimedean screw, hydrodynamic screw, water screw or Egyptian screw, is one of the earliest hydraulic machines. Using Archimedes screws as water pumps (Archimedes screw pump (ASP) or screw pump) dates back ...
; and an experimental artificial heart designed by Bud Frazier and Billy Cohn, using turbines spinning at 8,000 to 12,000 RPMs.
A centrifugal artificial heart which alternately pumps the
pulmonary circulation
The pulmonary circulation is a division of the circulatory system in all vertebrates. The circuit begins with deoxygenated blood returned from the body to the right atrium of the heart where it is pumped out from the right ventricle to the lungs. ...
and the
systemic circulation
The blood circulatory system is a system of organs that includes the heart, blood vessels, and blood which is circulated throughout the entire body of a human or other vertebrate. It includes the cardiovascular system, or vascular system, tha ...
, causing a pulse, has been described.
Researchers have constructed a heart out of foam. The heart is made out of flexible silicone and works with an external pump to push air and fluids through the heart. It currently cannot be implanted into humans, but it is a promising start for artificial hearts.
Hybrid assistive devices
Patients who have some remaining heart function but who can no longer live normally may be candidates for ventricular assist devices (VAD), which do not replace the human heart but complement it by taking up much of the function.
The first Left Ventricular Assist Device (LVAD) system was created by
Domingo Liotta
Domingo Santo Liotta (29 November 1924 – 31 August 2022) was an Argentine surgeon and pioneer of heart surgery who created multiple cardiac prostheses, including the first total artificial heart used in a human being.
Early life
Domingo Sant ...
at
Baylor College of Medicine
Baylor College of Medicine (BCM) is a medical school and research center in Houston, Texas, within the Texas Medical Center, the world's largest medical center. BCM is composed of four academic components: the School of Medicine, the Graduate Sc ...
in
Houston
Houston (; ) is the most populous city in Texas, the most populous city in the Southern United States, the fourth-most populous city in the United States, and the sixth-most populous city in North America, with a population of 2,304,580 in ...
in 1962.
Another VAD, the Kantrowitz CardioVad, designed by
Adrian Kantrowitz
Adrian Kantrowitz (October 4, 1918 – November 14, 2008) was an American cardiac surgeon whose team performed the world's second heart transplant attempt (after Christiaan Barnard) at Maimonides Medical Center in Brooklyn, New York on December 6, ...
, boosts the native heart by taking up over 50% of its function.
Additionally, the VAD can help patients on the wait list for a heart transplant. In a young person, this device could delay the need for a transplant by 10–15 years, or even allow the heart to recover, in which case the VAD can be removed.
The artificial heart is powered by a battery that needs to be changed several times while still working.
The first heart assist device was approved by the FDA in 1994, and two more received approval in 1998.
While the original assist devices emulated the pulsating heart, newer versions, such as the Heartmate II, developed by The Texas Heart Institute of Houston, provide continuous flow. These pumps (which may be
centrifugal or
axial flow
An axial compressor is a gas compressor that can continuously pressurize gases. It is a rotating, airfoil-based compressor in which the gas or working fluid principally flows parallel to the axis of rotation, or axially. This differs from other ...
) are smaller and potentially more durable and last longer than the current generation of total heart replacement pumps. Another major advantage of a VAD is that the patient keeps the natural heart, which may still function for temporary back-up support if the mechanical pump were to stop. This may provide enough support to keep the patient alive until a solution to the problem is implemented.
In August 2006, an artificial heart was implanted into a 15-year-old girl at the
Stollery Children's Hospital
The Stollery Children's Hospital is a 218 bed children's hospital that opened in October 2001. It is a "hospital within a hospital," being situated within the University of Alberta Hospital and co-located with Mazankowski Alberta Heart Institute i ...
in
Edmonton
Edmonton ( ) is the capital city of the Canadian province of Alberta. Edmonton is situated on the North Saskatchewan River and is the centre of the Edmonton Metropolitan Region, which is surrounded by Alberta's central region. The city ancho ...
,
Alberta
Alberta ( ) is one of the thirteen provinces and territories of Canada. It is part of Western Canada and is one of the three prairie provinces. Alberta is bordered by British Columbia to the west, Saskatchewan to the east, the Northwest Ter ...
. It was intended to act as a temporary fixture until a donor heart could be found. Instead, the artificial heart (called a
Berlin Heart) allowed for natural processes to occur and her heart healed on its own. After 146 days, the Berlin Heart was removed, and the girl's heart functioned properly on its own. On 16 December 2011 the Berlin Heart gained U.S.
FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
approval. The device has since been successfully implanted in several children including a 4-year-old Honduran girl at
Children's Hospital Boston
Boston Children's Hospital formerly known as Children's Hospital Boston until 2012 is a nationally ranked, freestanding acute care children's hospital located in Boston, Massachusetts, adjacent both to its teaching affiliate, Harvard Medical Sch ...
.
Several continuous-flow ventricular assist devices have been approved for use in the European Union, and, as of August 2007, were undergoing clinical trials for FDA approval.
In 2012, Craig Lewis, a 55-year-old Texan, presented at the
Texas Heart Institute
The Texas Heart Institute is an independent, nonprofit organization that is improving cardiovascular health through trailblazing research, thought leadership, education, and patient care to forge a better future for those with cardiovascular diseas ...
with a severe case of
cardiac amyloidosis
Cardiac amyloidosis is a subcategory of amyloidosis where there is depositing of the protein amyloid in the cardiac muscle and surrounding tissues. Amyloid, a misfolded and insoluble protein, can become a deposit in the heart's atria, valves, or ...
. He was given an experiment continuous-flow artificial heart transplant which saved his life. Lewis died 5 weeks later of liver failure after slipping into a coma due to the
amyloidosis
Amyloidosis is a group of diseases in which abnormal proteins, known as amyloid fibrils, build up in tissue. There are several non-specific and vague signs and symptoms associated with amyloidosis. These include fatigue, peripheral edema, weight ...
.
In 2012, a study published in the New England Journal of Medicine compared the Berlin Heart to extracorporeal membrane oxygenation (ECMO) and concluded that "a ventricular assist device available in several sizes for use in children as a bridge to heart transplantation
uch as the Berlin Heartwas associated with a significantly higher rate of survival as compared with ECMO." The study's primary author, Charles D. Fraser Jr., surgeon in chief at Texas Children's Hospital, explained: "With the Berlin Heart, we have a more effective therapy to offer patients earlier in the management of their heart failure. When we sit with parents, we have real data to offer so they can make an informed decision. This is a giant step forward."
Suffering from end-stage heart failure, former Vice President
Dick Cheney
Richard Bruce Cheney ( ; born January 30, 1941) is an American politician and businessman who served as the 46th vice president of the United States from 2001 to 2009 under President George W. Bush. He is currently the oldest living former U ...
underwent a procedure at INOVA Fairfax Hospital, in Fairfax Virginia in July 2010, to have a Heartmate II VAD implanted.
In 2012, he received a heart transplant at age 71 after 20 months on a waiting list.
See also
*
Artificial heart valve
An artificial heart valve is a one-way valve implanted into a person's heart to replace a heart valve that is not functioning properly (valvular heart disease). Artificial heart valves can be separated into three broad classes: mechanical hear ...
*
Artificial cardiac pacemaker
An artificial cardiac pacemaker (or artificial pacemaker, so as not to be confused with the natural cardiac pacemaker) or pacemaker is a medical device that generates electrical impulses delivered by electrodes to the chambers of the heart ei ...
References
General references
* George B. Griffenhagen and Calvin H. Hughes. ''The History of the Mechanical Heart''. Smithsonian Report for 1955, (Pub. 4241): 339–356, 1956.
"Donor saves Detroit pastor living on artificial heart" Fox News. 18 May 2018
Inline citations
External links
* Kembrey, Melanie (17 August 2010)
"Artificial heart a medical marvel" ''Fairfield City Champion''. Archived 6 July 2011.
{{DEFAULTSORT:Artificial Heart
American inventions
Implants (medicine)
Cardiology
Heart
The heart is a muscular organ in most animals. This organ pumps blood through the blood vessels of the circulatory system. The pumped blood carries oxygen and nutrients to the body, while carrying metabolic waste such as carbon dioxide t ...
1937 in medicine
20th-century inventions